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MESI mTABLET ABI

FDA UDI

Class II (US FDA UDI)

by MESI d.o.o.

Identity

Trade Name
MESI mTABLET ABI FDA UDI
Generic Name
Noninvasive ankle brachial pressure index measurement unit FDA UDI
Device Name
The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, viewing and storing ankle-brachial index (ABI) measurement of adult patients –patients in the PAD risk group. It is a wireless system which is comprised of a wireless medical tablet system, four tubeless blood pressure cuff modules and a 4-port charging station module. FDA UDI
Model / Reference
MTABSYSABI FDA UDI
Description
The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, viewing and storing ankle-brachial index (ABI) measurement of adult patients –patients in the PAD risk group. It is a wireless system which is comprised of a wireless medical tablet system, four tubeless blood pressure cuff modules and a 4-port charging station module. FDA UDI

Identifiers

Catalog Number
301-003015 FDA UDI
Primary DI / UDI-DI
03830059851141 FDA UDI
510(k) Number
K201046 FDA UDI
FDA Product Code
JOM FDA UDI
GMDN Term
Noninvasive ankle brachial pressure index measurement unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Noninvasive ankle brachial pressure index measurement unit

MESI mTABLET ABI by MESI d.o.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive ankle brachial pressure index measurement unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MESI d.o.o.

Sources (1)

  • FDA UDI 2a109c9c-8357-48d3-958a-5a8dc6981c8f 35 fields · synced May 31, 2026